Medication info
Sitagliptin Alpha Tablets 50 mg (Sitagliptin Hydrochloride Monohydrate)

Sitagliptin Alpha Tablets 50 mg (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
Pale yellowish-pink, round, biconvex film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP×3]
Approval status
Active

MFDS item code 202004068 · Approved 2020.05.29 · Insurance code 669908000

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is administered as a single daily dose of 100 mg, with a maximum daily dose of 100 mg when used alone or in combination therapy. It can be taken regardless of meals. In patients with renal impairment, dosage adjustments are required, reducing to 50 mg or 25 mg based on glomerular filtration rate. - Dosage adjustments are not necessary for mild and moderate renal impairment (glomerular filtration rate between 45 and 90 mL/min).

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

  • Difficulty in blood sugar control in patients with type 2 diabetes
View approved original text

This medication is used to help control blood sugar levels in patients with type 2 diabetes. It can be administered alone or in combination with meal and exercise therapy, and can be used alone or with metformin in cases where the patient has no prior drug treatment experience. Additionally, this medication is used in combination with medications like sulfonylureas, metformin, thiazolidinediones, or insulin when adequate blood sugar control cannot be achieved with monotherapy. It is also used to aid blood sugar control in cases of insufficient control with complex combination therapy. This medication is utilized to improve blood sugar control in various treatment scenarios.

How to take

Adult dose

This medication is administered as a single daily dose of 100 mg, with a maximum daily dose of 100 mg when used alone or in combination therapy. It can be taken regardless of meals. In patients with renal impairment, dosage adjustments are required, reducing to 50 mg or 25 mg based on glomerular filtration rate. - Dosage adjustments are not necessary for mild and moderate renal impairment (glomerular filtration rate between 45 and 90 mL/min).

Precautions

This medication may cause severe allergic reactions after administration; therefore, if symptoms such as skin rash or difficulty breathing occur, use should be stopped immediately and consultation with a physician is advised. This medication may cause serious inflammation of the pancreas known as pancreatitis, so if symptoms such as abdominal pain, vomiting, or fever appear, it is crucial to inform medical personnel immediately. It should not be used in patients with type 1 diabetes or diabetic ketoacidosis, nor in patients who have had allergic reactions to this medication or its components. In patients with impaired kidney function, dosage adjustments are necessary, so regular kidney function tests should be conducted. When used with other blood sugar-lowering agents, especially insulin or sulfonylureas, there is an increased risk of hypoglycemia, so blood sugar levels must be monitored carefully. This medication may induce severe joint pain or skin diseases such as bullous pemphigoid, so if such symptoms occur, medical advice should be sought immediately. Women who are pregnant or breastfeeding are advised to avoid using this medication, and its safety and efficacy have not been established in children or adolescents under 18. Elderly patients may have diminished kidney function, necessitating dosage adjustments and regular monitoring of kidney function. In cases of overdose, standard treatment protocols apply, and blood dialysis may remove some of this medication, so dialysis treatment should be considered if needed. This medication has relatively few interactions with other drugs, but should be discussed with a physician when taken alongside specific medications.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), anaphylaxis, exfoliative skin disorders including Stevens-Johnson syndrome, acute pancreatitis, worsening renal function (including acute renal failure), severe and debilitating joint pain, bullous pemphigoid, severe hypoglycemia, pneumonia, diabetic complications, metabolic acidosis, falls, cardiac arrest

Mild side effects

  • Nasopharyngitis
  • upper respiratory infection
  • headache
  • diarrhea
  • nausea
  • constipation
  • myalgia
  • limb pain
  • back pain
  • pruritus
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  • thrombocytopenia
  • dyspepsia
  • dizziness
  • increased blood triglycerides
  • elevated low-density lipoprotein
  • hyperglycemia
  • weight loss
  • hypertension
  • hypernatremia
  • erectile dysfunction

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a sealed container to prevent exposure to air and should be kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Pale yellowish-pink, round, biconvex film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP×3]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.